IHE Eye Care Technical Framework Supplement

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Integrating the Healthcare Enterprise 5 IHE Eye Care Technical Framework Supplement 10 Eye Care Summary Record (EC-Summary) 15 Rev. 1.2 - Trial Implementation 20 Date: August xx, 2017 Author: IHE Eye Care Technical mmittee Email: eyecare@ihe.net December x 25 Please verify you have the most recent version of this document. See here for Trial Implementation and Final Text versions and here for Public mment versions. pyright 2017: IHE International

35 40 45 Foreword This is a supplement to the IHE Eye Care Technical Framework V4.0. Each supplement undergoes a process of public comment and trial implementation before being incorporated into the volumes of the Technical Frameworks. This supplement is published on December xx, 2016 for trial implementation and may be available for testing at subsequent IHE nnectathons. The supplement may be amended based on the results of testing. Following successful testing it will be incorporated into the Eye Care Technical Framework. mments are invited and can be submitted at http://ihe.net/eye_care_public_mments. This supplement describes changes to the existing technical framework documents and where indicated amends text by addition (bold underline) or removal (bold strikethrough), as well as addition of large new sections introduced by editor s instructions to add new text or similar, which for readability are not bolded or underlined. Boxed instructions like the sample below indicate to the Volume Editor how to integrate the relevant section(s) into the relevant Technical Framework volume: 3.7 July 14, 2015 Replace Section X.X by the following: 50 55 General information about IHE can be found at: www.ihe.net. Information about the IHE Eye Care domain can be found at: ihe.net/ihe_domains. Information about the organization of IHE Technical Frameworks and Supplements and the process used to create them can be found at: http://ihe.net/ihe_process and http://ihe.net/profiles. The current version of the IHE Eye Care Technical Framework can be found at: http://ihe.net/technical_frameworks. 2 HL7, HEALTH LEVEL SEVEN, 2... [1] 2.0 yyyy-mm-dd

CONTENTS 65 70 75 80 85 90 95 100 Introduction to this Supplement... 5 Open Issues and Questions... 5 Closed Issues... 5 General Introduction... 6 Appendix A - Actor Summary Definitions... 6 Appendix B - Transaction Summary Definitions... 6 Glossary... 6 Volume 1 Profiles... 7 pyright Licenses... 7 Domain-specific additions... 7 1.7 History of Annual Changes... 7 2.2.7 Eye Care Summary Record ntent Profile... 7 9 Eye Care Summary Record (EC-Summary) ntent Profile... 8 9.1 EC-Summary Actors, Transactions and ntent Modules... 8 9.1.1 Actor Descriptions and Actor Profile Requirements... 9 9.1.1.1 ntent Creator... 9 9.1.1.2 ntent nsumer... 10 9.2 EC-Summary Actor Options... 10 9.3 Required Actor Groupings... 10 9.4 EC-Summary Overview... 11 9.4.1 ncepts... 11 9.4.2 Use Cases... 11 9.4.2.1 Use Case #1: Glaucoma... 12 9.4.2.1.1 Glaucoma Use Case Description... 12 9.4.2.2 Use case #2: mplete Transfer of Patient Care... 12 9.4.2.2.1 mplete Transfer of Care Description... 12 9.4.2.3 Use Case #3: Provider or practice migrates to a new EHR... 13 9.4.2.3.1 Provider or practice migrates to new EHR Description... 13 9.4.2.4 Use Case #4: Sending or receiving EHR is not able to create or import discrete data elements found in Eye Care CDAs... 13 9.4.2.4.1 Sending or receiving EHR is not able to create or import discrete data elements found in Eye Care CDAs Description... 13 9.5 EC-Summary Security nsiderations... 13 9.6 EC-Summary Cross Profile nsiderations... 13 Volume 2 Transactions... 15 Volume 3 ntent Modules... 15 5 Namespaces and Vocabularies... 15 6 ntent Modules... 16 6.3 CDA Release 2 ntent Modules... 16 6.3.1 CDA Document ntent Modules... 16 3 Mary Jungers 12/19/2016 7:18 PM Formatted: Font:Bold 7 HL7, HEALTH LEVEL SEVEN, 2... [2] 2.0 yyyy-mm-dd 9 13 13 14 Mary Jungers 12/19/2016 7:18 PM Formatted: Font:Bold 15 16 17 19 19 19

115 120 125 130 135 6.3.1.1 General Eye Evaluation (GEE) C-CDA Progress Note Document ntent Module) (1.3.6.1.4.1.19376.1.12.1.1.2)... 16 6.3.1.2 General Eye Evaluation (GEE) C-CDA nsult Note Document ntent Module) (1.3.6.1.4.1.19376.1.12.1.1.3)... 16 6.3.1.3 Eye Care Summary Record (EC-Summary) Document ntent Module (1.3.6.1.4.1.19376.1.12.1.1. 4)... 16 6.3.1.3.1 Parent Template... 16 6.3.1.3.2 Relationship to C-CDA... 17 6.3.1.3.3 XDS Metadata Extensions for EC-Summary... 17 6.3.1.3.4 Eye Care Summary Header Section... 17 6.3.1.3.5 Eye Care Summary Specification... 18 6.3.2 CDA Section ntent Modules... 22 6.3.2.20 Ocular Encounter Summary 1.3.6.1.4.1.19376.1.12.1.2.20... 22 19 19 19 19 19 20 20 20 24 24 Introduction to this Supplement 5... [4] Formatted... [5] 4 HL7, HEALTH LEVEL SEVEN, 2... [3]

165 170 175 180 185 Introduction to this Supplement The Eye Care Summary Record (EC-Summary) describes the structure of data that is collected for a patient s eye care summary medical record, generally for the purpose of transfer or referral of care to another provider. This supplement is written as changes to the documents listed below. The reader should have already read and understood these documents: 1. IHE Eye Care Technical Framework Volume 1, Integration Profiles 2. IHE Eye Care Technical Framework Volume 2, Transactions This supplement also references other documents 1. The reader should have already read and understood these documents: 1. IHE Eye Care C-CDA based General Eye Evaluation Trial Implementation 2. IT Infrastructure Technical Framework Volume 1 3. IT Infrastructure Technical Framework Volume 2 4. IT Infrastructure Technical Framework Volume 3 5. IHE Patient Care ordination Technical Framework Volume 1 6. IHE Patient Care ordination Technical Framework Volume 2 7. HL7 2 Implementation Guide for CDA 3 Release 2: IHE Health Story nsolidation, DSTU Release 1.1 (US Realm) Draft Standard for Trial Use July 2012 8. HL7 and other standards documents referenced in Volume 1 and Volume 2 Open Issues and Questions None Closed Issues None 1 The first six documents can be located on the IHE Website at http://ihe.net/technical_frameworks. The remaining documents can be obtained from their respective publishers. 2 HL7 is the registered trademark of Health Level Seven 3 CDA is the registered trademark of Health Level Seven 5 Mary Jungers 12/19/2016 7:12 PM CDA Mary Jungers 12/19/2016 7:10 PM Formatted: Superscript Mary Jungers 12/19/2016 7:12 PM Formatted: Superscript HL7, HEALTH LEVEL SEVEN, 2... [6] 2.0 yyyy-mm-dd

190 General Introduction Update the following Appendices to the General Introduction as indicated below. Note that these are not appendices to Volume 1. Appendix A - Actor Summary Definitions Add the following actors to the IHE Technical Frameworks General Introduction list of actors: No new actors. Mary Jungers 12/19/2016 7:09 PM A 195 200 Appendix B - Transaction Summary Definitions Add the following transactions to the IHE Technical Frameworks General Introduction list of Transactions: No new transactions. Glossary Add the following glossary terms to the IHE Technical Frameworks General Introduction Glossary: No new glossary terms. 6 HL7, HEALTH LEVEL SEVEN, 2... [7] 2.0 yyyy-mm-dd

205 Volume 1 Profiles pyright Licenses NA 210 215 Domain-specific additions NA Add the following to Section 1.7 1.7 History of Annual Changes Added a ntent Profile that defines the structure of the data that is collected to capture a patient s eye care summary medical record. Eye Care Summary Record (EC-Summary) 220 225 230 Add the following section to Section 2.2 2.2.7 Eye Care Summary Record ntent Profile The Eye Care Summary Record (EC-Summary) consists of one content profile. This profile defines the structure of data that is collected for a patient s eye care summary medical record, generally for the purpose of transfer or referral of care to another provider. The United States Office of the National ordinator for Health Information Technology (ONC) is the principal federal entity charged with coordination of nationwide efforts to implement and use the most advanced health information technology and the electronic exchange of health information. ONC HIT certification adopted the HL7 nsolidated CDA (C-CDA) Implementation Guide to exchange clinical documents (i.e., patient s summary of care record, consultation notes, progress notes, etc.). The C-CDA defines specifications for many general medical sections such as medications, allergies, chief complaint, problems, and more. The Eye Care Summary Record (EC-Summary) ntent Profile specifies many of the same applicable general sections as defined by ONC and in addition includes sections specific to a patient s eye care summary medical record. 7 Don Van Syckle 7/25/2017 11:32 AM Final Rule for Stage 2 of the EHR Incentive Program aka Meaningful Use (MU2) Don Van Syckle 7/25/2017 11:32 AM in Don Van Syckle 7/25/2017 11:32 AM MU2 HL7, HEALTH LEVEL SEVEN, 2... [8] 2.0 yyyy-mm-dd

240 245 250 255 260 IHE Eye Care has decided to create a content profile that is a superset of the summary based C- CDA specification selected for ONC. It is a superset of the C-CDA ntinuity of Care (CCD 4 ) document. Add Section 9 9 Eye Care Summary Record (EC-Summary) ntent Profile The Eye Care Summary Record (EC-Summary) consists of one content profile. This profile defines the structure of data that is collected for a patient s eye care summary medical record, generally for the purpose of transfer or referral of care to another provider. The United States Office of the National ordinator for Health Information Technology (ONC) is the principal federal entity charged with coordination of nationwide efforts to implement and use the most advanced health information technology and the electronic exchange of health information. ONC HIT certification adopted the HL7 nsolidated CDA (C-CDA) Implementation Guide to exchange clinical documents (i.e., patient s summary of care record, consultation notes, progress notes, etc.). The C-CDA defines specifications for many general medical sections such as medications, allergies, chief complaint, problems, and more. The Eye Care Summary Record (EC-Summary) ntent Profile specifies many of the same applicable general sections as defined by ONC in addition to sections specific to eye care. IHE Eye Care has decided to create a content profile that is a superset of the summary based C- CDA specification selected for ONC. It is a superset of the C-CDA ntinuity of Care (CCD) document. Note: Access to DICOM 5 data (i.e., images, measurements, reports) is very important for the patient summary record. This capability is not defined in this content profile but IHE Eye Care highly recommends that a DICOM CD be available for the patient. 9.1 EC-Summary Actors, Transactions and ntent Modules This section defines the actors, transactions, and/or content modules in this profile. General definitions of actors are given in the Technical Frameworks General Introduction Appendix A at http://ihe.net/technical_frameworks/. 4 CCD is the registered trademark of Health Level Seven 5 DICOM is the registered trademark of the National Electrical Manufacturers Association for its standards publications relating to digital communications of medical information. 8 Don Van Syckle 7/25/2017 12:43 PM MU2 Mary Jungers 12/19/2016 7:11 PM Formatted: Superscript Don Van Syckle 7/25/2017 11:35 AM Final Rule for Stage 2 of the EHR Incentive Program aka Meaningful Use (MU2) Don Van Syckle 7/25/2017 11:35 AM in Don Van Syckle 7/25/2017 11:35 AM MU2 Don Van Syckle 7/25/2017 11:36 AM MU2 Mary Jungers 12/19/2016 7:10 PM Formatted: Superscript HL7, HEALTH LEVEL SEVEN, 2... [9] 2.0 yyyy-mm-dd

275 280 Figure 9.1-1 shows the actors directly involved in the EC-Summary Profile and the direction in which the content is exchanged. A product implementation using this profile must group actors from this profile with actors from a workflow or transport profile to be functional. The grouping of the content module described in this profile to specific actors is described in more detail in the Required Actor Groupings section below. There are two actors in this profile, the ntent Creator and the ntent nsumer. ntent is created by a ntent Creator and is consumed by a ntent nsumer. The sharing or transmission of content from one actor to the other may be addressed by the appropriate use of IHE profiles described in the section on ntent Bindings with XDS, XDM and XDR in PCC TF-2:4.1 and is out of scope of this profile. Figure 9.1-1: Actor Diagram 285 290 295 Table 9.1-1 lists the content module(s) defined in the EC-Summary Profile. To claim support for this profile, an actor shall support all required content modules (labeled R ) and may support optional content modules (labeled O ). Table 9.1-1: EC-Summary Profile - Actors and ntent Modules Actors ntent Modules Optionality Reference ntent Creator ntent nsumer Eye Care Summary Record 1.3.6.1.4.1.19376.1.12.1.1.4 Eye Care Summary Record 1.3.6.1.4.1.19376.1.12.1.1.4 9.1.1 Actor Descriptions and Actor Profile Requirements 9 R R EYECARE TF-3: 6.3.1.3 EYECARE TF-3: 6.3.1.3 Most requirements are documented in Transactions (Volume 2) and ntent Modules (Volume 3). This section documents any additional requirements for this profile s actors. 9.1.1.1 ntent Creator 1. A ntent Creator shall be able to create an eye care patient summary document according to the Eye Care Summary Record Document (1.3.6.1.4.1.19376.1.12.1.1.4) that is found in EYECARE TF-3 6.3.1.3. Lynn 12/19/2016 9:03 PM EyeCare Lynn 12/19/2016 9:03 PM EyeCare HL7, HEALTH LEVEL SEVEN, 2... [10] 2.0 yyyy-mm-dd

300 305 310 315 320 325 9.1.1.2 ntent nsumer 1. A ntent nsumer shall be able to consume (receive and process) the Eye Care Summary Record Document (1.3.6.1.4.1.19376.1.12.1.1.4) that is found in EYECARE TF-3: 6.3.1.3. 2. A ntent nsumer shall implement the View Option or Discrete Data Import Option, or both. a) For View Option, the ntent nsumer shall conform to IHE PCC TF-2: 3.1.1. b) For Discrete Data Import Option, the ntent nsumer shall conform to IHE PCC TF-2: 3.1.4. 3. A ntent nsumer that implements the Section Import Option shall conform to IHE PCC TF-2: 3.1.3. 4. A ntent nsumer that implements the Discrete Data Import Option shall PCC TF-2: 3.1.2. 9.2 EC-Summary Actor Options Options that may be selected for each actor in this profile, if any, are listed in the Table 9.2-1. Dependencies between options when applicable are specified in notes. Table 9.2-1: Eye Care Summary Record Options Actor Option Section ntent nsumer ntent Creator 9.3 Required Actor Groupings View Option (See Section 9.1.1.2) Document Import Option (See Section 9.1.1.2) Section Import Option (See Section 9.1.1.2) Discrete Data Import Option (See Section 9.1.1.2) Shall implement the Eye Care Summary Document (1.3.6.1.4.1.19376.1.12.1.1.4). 10 PCC TF-2: 3.1.1 PCC TF-2: 3.1.2 PCC TF-2: 3.1.3 PCC TF-2: 3.1.4 EYECARE TF-3: 6.3.1.3 This section describes the behaviors expected of the ntent Creator and ntent nsumer actors of this profile when grouped with actors of other IHE profiles. No grouping rules are specified. IHE Eye Care recommends that the ntent Creator and ntent nsumer support at least one of the IHE and/or Direct Messaging exchange profiles. IHE XDS, IHE XDR, IHE XDM XDR and XDM for Direct Messaging, Version 1, Finalized 9 March 2011 Don Van Syckle 12/20/2016 4:21 PM Formatted: Numbered + Level: 1 + Numbering Style: a, b, c,... + Start at: 1 + Alignment: Left + Aligned at: 0.75" + Indent at: 1" Lynn 12/19/2016 9:03 PM mment [1]: See my comments in GEE about restating these requirements Don ok updated like GEE Don Van Syckle 12/20/2016 4:20 PM <#>A ntent nsumer that implements the Document Import or Section Import Option shall implement the View Option as well.... [12] HL7, HEALTH LEVEL SEVEN, 2... [11] 2.0 yyyy-mm-dd

335 340 345 350 355 360 365 IHE Eye Care Technical Framework Supplement Eye Care Summary Record (EC-Summary) 9.4 EC-Summary Overview Change referenced section numbering when merged into technical framework The Eye Care Summary Record (EC-Summary) consists of one content profile. This profile defines the structure of data that is collected for a patient s eye care summary medical record. EC-Summary is a customized extension of the C-CDA specifications chosen to align with the ONC Health IT Certification Program, as currently required within USA for MIPS. This facilitates: a. Increasing interoperability with systems that support the ONC program b. Reducing the burden on ONC-certified EHR systems that simultaneously support IHE Eye Care c. Easing the burden for organizations incorporating eye care patient summary records into their EHRs Although EC-Summary extends the C-CDA ntinuity of Care document (CCD), IHE Eye Care does not specify or reference any ONC requirements extending the C-CDA standard. Vendors seeking to create documents simultaneously compliant with this IHE profile and ONC certification criteria must evaluate compliance with ONC certification requirements separately from and in addition to compliance with this profile. The potential benefit to the ophthalmologist or optometrist may be to satisfy CMS care coordination requirements such as for referrals and transitions of care under MIPS, while simultaneously providing (or receiving) sufficient eye care information so as to be useful to another ophthalmologist or optometrist. Furthermore, IHE EC-Summary is intended to support providing eye-care-specific structured data to specialized registries such as IRIS or MORE, or other quality registries or quality data warehouses of ACOs or other APM Entities. 9.4.1 Use Cases Change referenced section numbering when merged into technical framework mprehensive eye care deals with a broad spectrum of subspecialty disciplines each with its own lexicon, examination techniques, and procedures. A patient presents for an examination and demographic data is created, retrieved from existing databases, or updated. The patient provides a chief complaint, general medical information, and historical information relevant to the eye, and a partial or complete examination of the eye and visual system is performed. Multiple people may contribute to this process including receptionist, technician, and physician. The American Academy of Ophthalmology Preferred Practice Pattern for a mprehensive Adult Medical Eye Evaluation provides a roadmap for data collection. The nature of the data varies widely and may be discrete and defined by existing terminology standards (e.g., visual acuity, intraocular pressure) or narrative and available only as free text (e.g., description of a lesion). After this data is collected the clinician will arrive at an assessment and management 11 Don Van Syckle 7/25/2017 12:18 PM MU2. Don Van Syckle 7/25/2017 12:22 PM Don Van Syckle 7/25/2017 11:37 AM MU2 Don Van Syckle 7/25/2017 12:23 PM and MU2 Don Van Syckle 7/25/2017 12:31 PM aligns Don Van Syckle 7/25/2017 12:31 PM with Don Van Syckle 7/25/2017 12:31 PM summary based document specified by MU2 (i.e., Don Van Syckle 7/25/2017 12:36 PM ) Don Van Syckle 7/25/2017 12:33 PM determine whether or not systems support MU2. Vendors needs to verify themselves if they are both MU2 and EC-Summary compliant.... [15] Lynn 12/19/2016 9:05 PM mment [2]: Why is this section empty? Don good question, deleted. Don Van Syckle 7/25/2017 12:43 PM Vendors may create a C-CDA based ntinuity of Care (CCD) document which can be used to satisfy MU2 and the IHE EC-Summary requirements simultaneously. Thus, an ophthalmologist or optometrist may provide the patient with a patient summary record which simultaneously satisfies MU2 and contains sufficient eye care information to be useful. It is important for implementers to understand that they, and not... IHE [16] Don Van Syckle 12/20/2016 5:17 PM 2 HL7, HEALTH LEVEL SEVEN,... [13] 2... [14] 2.0 yyyy-mm-dd

415 420 425 430 435 440 445 plan. All of this must be recorded in a fashion that will allow subsequent transfer across diverse information platforms without loss of content or meaning using existing standards and protocols. IHE defines the General Eye Evaluation (GEE) ntent Profile to document these patient encounters. During the course of a patient s care, services may be needed by a variety of subspecialty providers. The patient may need to move his/her care in part or whole to another provider. The safe and effective transfer or referral of an eye care patient to another provider requires an appropriate summary of the eye care record. IHE defines the Eye Care Summary Record (EC- Summary) ntent Profile to document this summary record. By its nature, this summary does not include all the details from each individual patient encounter (GEE). Therefore, if the organization providing healthcare services wishes to consume all the patient encounter information, the patient s encounter documents (GEE) should be transferred as well as the patient s summary (EC-Summary). The goal of this EC-Summary is to provide key historical data that will satisfy the needs of most eye care providers for care of a new patient. The data in this summary document is not exhaustive, and may not satisfy the needs of all specialty providers. Nevertheless, the clinical summary is an important clinical tool for continuity of care, whether or not it is accompanied by all detailed patient encounter documentation. Even in the setting of ongoing care of a patient by a single provider, a succinct summary allows the provider to recognize in context important details that may otherwise be missed among the large volume of data in the medical record. 9.4.1.1 Use Case #1: Glaucoma 9.4.1.1.1 Glaucoma Use Case Description Transfer of care for a glaucoma patient is especially dependent upon historical data. Determination of clinical targets for disease control requires careful review of multiple data points over time and in relationship to each other, such as intraocular pressure, cup/disc ratio, optic disc hemorrhages, visual field, retinal nerve fiber layer thickness, pachymetry, eye medications, adverse drug reactions, etc. Ability to quickly review of all of these data points in proper context would greatly facilitate patient safety and quality care by the receiving eye care practitioner. The data points used in glaucoma management are especially important to include in a patient s summary of care. Even if documentation of every past patient encounter is included in the transfer of records, these data points can be difficult to find and evaluate if a succinct summary is not provided. 9.4.1.2 Use case #2: mplete Transfer of Patient Care 9.4.1.2.1 mplete Transfer of Care Description When circumstances require a complete transfer in care from one provider to another, continuity of care can be possible only with a complete transfer of the patient s medical data. There is no substitute for a comprehensive transfer of all patient encounter content accumulated during the course of the patient s care by the transferring provider. However, a succinct summary of this 12 Don Van Syckle 12/20/2016 5:18 PM Formatted: Outline numbered + Level: 4 + Numbering Style: 1, 2, 3,... + Start at: 1 + Alignment: Left + Aligned at: 0" + Indent at: 0.75" Don Van Syckle 12/20/2016 5:18 PM Formatted: No bullets or numbering Don Van Syckle 12/20/2016 5:18 PM Formatted: Outline numbered + Level: 4 + Numbering Style: 1, 2, 3,... + Start at: 1 + Alignment: Left + Aligned at: 0" + Indent at: 0.75" Don Van Syckle 12/20/2016 5:19 PM Formatted: Outline numbered + Level: 5 + Numbering Style: 1, 2, 3,... + Start at: 1 + Alignment: Left + Aligned at: 0" + Indent at: 0.75" HL7, HEALTH LEVEL SEVEN, 2... [17] 2.0 yyyy-mm-dd

450 455 460 465 470 475 480 information is still important to provide the receiving provider a proper understanding of the patient s key status and needs. 9.4.1.3 Use Case #3: Provider or practice migrates to a new EHR 9.4.1.3.1 Provider or practice migrates to new EHR Description The ophthalmic community has a large installed user base of a wide variety of EHRs. For reasons including evolving regulatory constraints, market influence, and personal preference providers are frequently choosing to migrate from one eye care EHR to another. Ideally a provider would want all of the data collected in his/her current EHR to migrate to the new one, but this has proven to be difficult and costly even when similar data elements are being stored by the various EHRs. The EC-Summary Profile provides a data migration option for conforming eye care EHRs. The goal of this profile is to provide key data that will satisfy the needs of most eye care providers for ongoing care of their patients. The data in this summary document is not exhaustive, and may not satisfy the needs of all specialty providers when migrating from one EHR system to another. 9.4.1.4 Use Case #4: Sending or receiving EHR is not able to create or import discrete data elements found in Eye Care CDAs 9.4.1.4.1 Sending or receiving EHR is not able to create or import discrete data elements found in Eye Care CDAs Description Various EHRs may conform to specifications for GEE or EC-Summary Profiles to different degrees. Some may be able to create or import every data element specified, and some may only be able to create or receive a viewable document. In the latter case the receiving EHR would only be able to receive and display the document, and would not be able to import the discrete data elements (e.g., intraocular pressure measurements over time) into the appropriate locations in its own database. 9.5 Grouping This section describes the behaviors expected of the ntent Creator and ntent nsumer actors of this profile when grouped with actors of other IHE profiles. No grouping rules are specified. IHE Eye Care recommends that the ntent Creator and ntent nsumer support at least one of the IHE and/or Direct Messaging exchange profiles. IHE XDS, IHE XDR, IHE XDM XDR and XDM for Direct Messaging, Version 1, Finalized 9 March 20119 9.6 EC-Summary Cross Profile nsiderations A ntent Creator of EC-Summary might be grouped with a ntent Creator of GEE so that it has the ability to generate a patient s encounter document. 13 Don Van Syckle 12/20/2016 5:18 PM Formatted: Outline numbered + Level: 4 + Numbering Style: 1, 2, 3,... + Start at: 1 + Alignment: Left + Aligned at: 0" + Indent at: 0.75" Don Van Syckle 12/20/2016 5:18 PM Formatted: Outline numbered + Level: 5 + Numbering Style: 1, 2, 3,... + Start at: 1 + Alignment: Left + Aligned at: 0" + Indent at: 0.75" Don Van Syckle 12/20/2016 5:18 PM Formatted: Outline numbered + Level: 4 + Numbering Style: 1, 2, 3,... + Start at: 1 + Alignment: Left + Aligned at: 0" + Indent at: 0.75" Don Van Syckle 12/20/2016 5:18 PM Formatted: Outline numbered + Level: 5 + Numbering Style: 1, 2, 3,... + Start at: 1 + Alignment: Left + Aligned at: 0" + Indent at: 0.75" Mary Jungers 12/19/2016 7:07 PM p Lynn 12/19/2016 9:06 PM mment [3]: But you don t have any grouped actors, Don - added the no grouping discussion to be the same as GEE Don Van Syckle 12/20/2016 5:22 PM 9.5 EC-Summary Security nsiderations... [19] HL7, HEALTH LEVEL SEVEN, 2... [18] 2.0 yyyy-mm-dd

490 A ntent nsumer of EC-Summary might be grouped with a ntent nsumer of GEE so that it has the ability to consume a patient s encounter document. 14 HL7, HEALTH LEVEL SEVEN, 2... [20] 2.0 yyyy-mm-dd

495 500 505 NA Volume 2 Transactions and ntent Modules Add to Section 5.1 IHE Format des The table below lists the format codes, root template identifiers and media types used by the IHE Profiles specified in the Eye Care Technical Framework. Note: The code system for these codes is 1.3.6.1.4.1.19376.1.2.3 as assigned by the ITI Domain for codes used for the purposes of cross-enterprise document sharing (XDS). Profile Format de Media Type Eye Care Summary Record (EC-Summary) Update Section 6 15 Template ID urn:ihe:eyecare:summary:2015 text/xml 1.3.6.1.4.1.19376.1.12.1.1.4 Don Van Syckle 7/25/2017 12:55 PM Volume 3 ntent Modules Don Van Syckle 7/25/2017 12:59 PM mment [4]: Already included in GEE so do not need to add here Don Van Syckle 7/25/2017 12:59 PM 5 Namespaces and Vocabularies Don Van Syckle 7/25/2017 12:59 PM codesystemname... [22] Don Van Syckle 7/25/2017 1:00 PM.1 Lynn 12/19/2016 9:06 PM Formatted Table Don Van Syckle 7/25/2017 1:01 PM mment [5]: Already in GEE so do not add here Don Van Syckle 7/25/2017 1:01 PM General Eye Evaluation (GEE) C-CDA Progress Note... [23] Don Van Syckle 7/25/2017 1:00 PM Formatted: Font:Bold, Underline Don Van Syckle 7/25/2017 1:00 PM Formatted: Font:Bold, Underline Don Van Syckle 7/25/2017 1:00 PM Formatted: Font:Times New Roman, Underline, Check spelling and grammar Don Van Syckle 7/25/2017 1:00 PM Formatted: Font:Times New Roman, Underline, Check spelling and grammar Don Van Syckle 7/25/2017 1:01 PM Add to Section 5.1.2 IHE Actde Vocabulary... [24] HL7, HEALTH LEVEL SEVEN, 2... [21] 2.0 yyyy-mm-dd

6 ntent Modules 520 6.3 CDA Release 2 ntent Modules 6.3.1 CDA Document ntent Modules 6.3.1.1 General Eye Evaluation (GEE) C-CDA Progress Note Document ntent Module) (1.3.6.1.4.1.19376.1.12.1.1.2) 525 530 535 540 545 6.3.1.2 General Eye Evaluation (GEE) C-CDA nsultation Note Document ntent Module) (1.3.6.1.4.1.19376.1.12.1.1.3) 6.3.1.3 Eye Care Summary Record (EC-Summary) Document ntent Module (1.3.6.1.4.1.19376.1.12.1.1. 4) The Eye Care Summary Record (EC-Summary) is a content profile that defines the structure of data that is contained in a patient s eye care summary medical record. It is designed to be an extension to the C-CDA ntinuity of Care (CCD) document. 1. The templateid/@root for conformance to this document SHALL be 1.3.1.4.1.19376.1.12.1.1.4 to assert conformance to this template. 2. The ClinicalDocument/code LOINC code for the document SHALL be 78512-1, Ophthalmology Summary Note. 3. The XDSDocumentEntry format code for this content SHALL be urn:ihe:eyecare:summary:2015. 4. The mapping of CDA header attributes to XDS metadata SHALL be identical to the XDS-MS mapping specified in PCC TF-2: 4.1.1. EC-Summary specific extensions are shown in Section 6.3.1.3.3. Note: Although the LOINC organization created the document title code 78512-1, Ophthalmology Summary Note, this document is intended to be used by both ophthalmology and optometry. 6.3.1.3.1 Parent Template The EC-Summary clinical document is an extension to the C-CDA ntinuity of Care (CCD) document. Therefore, the parent of this document template shall be: 1. C-CDA ntinuity of Care 2.16.840.1.113883.10.20.22.1.2 Note: Implementations may support other parent templates in addition to the CCD. 16 Don Van Syckle 12/20/2016 5:29 PM appliedforvalue Don Van Syckle 12/20/2016 5:28 PM Eye Care Don Van Syckle 7/26/2017 2:43 PM Formatted: Font:9 pt Don Van Syckle 7/26/2017 2:42 PM Formatted: Indent: Left: 0.25", Hanging: 0.25", No bullets or numbering HL7, HEALTH LEVEL SEVEN, 2... [25] 2.0 yyyy-mm-dd

555 560 565 570 575 6.3.1.3.2 Relationship to C-CDA Some CDA sections and entries used within this EC-Summary document are based on the HL7 Implementation Guide for CDA Release 2: IHE Health Story nsolidation, Release 1 DSTU (C-CDA) section and entry definitions. Specifically, it is a superset of the C-CDA ntinuity of Care. If there are no new or modified constraints for a section or entry or if only the value sets are constrained, then the definition of the section or entry is considered unchanged from the C-CDA definition and the C-CDA template ID will be used. These unchanged sections/entries are referenced directly to the C-CDA specification and are not included in this specification. 6.3.1.3.3 XDS Metadata Extensions for EC-Summary This section specifies extensions to the XDS metadata requirements defined by IHE ITI. 1. The XDSDocumentEntry classde LOINC code for the class SHALL be 78512-1, Ophthalmology Summary Note. 2. The XDSDocumentEntry practicesettingde for this content SHALL be 394594003, SNOMED CT, Ophthalmology 3. The XDSDocumentEntry typede LOINC code for the typede SHALL be 28619-5, Ophthalmology/Optometry Studies (set). 4. The XDSDocumentEntry typede code for the authorspecialty SHALL use SNOMED CT to identify the specialty of the author. a. The following codes are provided to express the scope of this attribute; additional SNOMED CT codes MAY be used. Note: Although the LOINC organization created the document title code 78512-1, Ophthalmology Summary Note, this document is intended to be used by both ophthalmology and optometry. SNOMED CT code 422234006, SNOMED CT, Ophthalmologist (occupation) 28229004, SNOMED CT, Optometrist (occupation) 6.3.1.3.4 Eye Care Summary Header Section 1. SHALL conform to the C-CDA ntinuity of Care Header nstraints specified in Section 3.1.1 of the HL7 Implementation Guide for CDA Release 2: IHE Health Story nsolidation, DSTU Release 1.1 (US Realm) Draft Standard for Trial Use July 2012. 17 Don Van Syckle 12/20/2016 5:31 PM appliedforvalue, Eye Care Don Van Syckle 12/20/2016 5:35 PM appliedforvalue, LOINC, Eye Care Don Van Syckle 7/26/2017 2:50 PM Formatted: Indent: Left: 0.25", Hanging: 0.25", No bullets or numbering Mary Jungers 12/19/2016 7:17 PM Formatted Table Mary Jungers 12/19/2016 7:12 PM CDA HL7, HEALTH LEVEL SEVEN, 2... [26] 2.0 yyyy-mm-dd

585 590 595 6.3.1.3.5 Eye Care Summary Specification The following table defines the Document ntent specification requirements. The OPT column is based upon the following criteria: 1. Specification based upon EC Summary is the main focus. The intent is that ntent Creators are required to support the ability to generate almost all sections based upon EC Summary. For example R[0..1], means implementations must be able to generate the sections, however for a specific instance it may be omitted if not filled in by the user generating the document. 2. Specification based upon C-CDA is defined similar to the specific C-CDA CCD specification except for when it is required by GEE. For example, the section Encounters is optional in the C-CDA CCD, however, R[0..1] for this document because it is required by EC Summary. 3. Specification based upon the IRIS Registry is always defined as optional, except for when it is required by EC Summary and/or C-CDA CCD. Don Van Syckle 7/25/2017 1:20 PM Don Van Syckle 7/25/2017 1:21 PM Formatted: Numbered + Level: 1 + Numbering Style: 1, 2, 3,... + Start at: 1 + Alignment: Left + Aligned at: 0.5" + Indent at: 0.75" Table 6.3.1.3.5-1: Eye Care Summary Record Document ntent Specification Template Name OPT Template Id Additional Requirements or mments CDA Header Modules M [1..1] See Section 6.3.1.3.4 Advanced Directive (entries optional) O[0..1] 2.16.840.1.113883.10.20.22.2.21 Allergies (entries required) R[1..1] 2.16.840.1.113883.10.20.22.2.6.1 Encounters (entries optional) O[0..1] 2.16.840.1.113883.10.20.22.2.22 Encounters (entries required) R[1..1] 2.16.840.1.113883.10.20.22.2.22. 1 18 This section is not specified in the C- CDA CCD but required for EC-Summary. Family History R[0..1] 2.16.840.1.113883.10.20.22.2.15 This section is optional in the C-CDA CCD but required for EC-Summary. Functional Status R[0..1] 2.16.840.1.113883.10.20.22.2.14 This section is optional in the C-CDA CCD but required for EC-Summary. Immunizations (entries optional) O[0..1] 2.16.840.1.113883.10.20.22.2.2 Medical Equipment O[0..1] 2.16.840.1.113883.10.20.22.2.23 Medications (entries required) R[1..1] 2.16.840.1.113883.10.20.22.2.1.1 Payers O[0..1] 2.16.840.1.113883.10.20.22.2.18 Plan of Care O[0..1] 2.16.840.1.113883.10.20.22.2.10 Problem (entries required) R[1..1] 2.16.840.1.113883.10.20.22.2.5.1 Procedure (entries required)* R[0..1] 2.16.840.1.113883.10.20.22.2.7.1 Note: Intended use is to generate a coded list of systemic and ocular procedures. Results (entries required) R[0..1] 2.16.840.1.113883.10.20.22.2.3.1 Social History R[0..1] 2.16.840.1.113883.10.20.22.2.17 This section is optional in the C-CDA HL7, HEALTH LEVEL SEVEN, 2... [27] 2.0 yyyy-mm-dd

605 610 615 620 625 Template Name OPT Template Id Additional Requirements or mments CCD but required for EC-Summary. Vital Signs (entries optional) O[0..1] 2.16.840.1.113883.10.20.22.2.4 Procedures (entries optional) R[0..1] 2.16.840.1.113883.10.20.22.2.7 This section is expected to be an accumulated list (free text) of systemic and ocular procedures. Ocular History* R[0..1] 1.3.6.1.4.1.19376.1.12.1.2.3 Note: Able to include a narrative description and coded Ocular Surgeries/Procedures, with dates, etc. Ocular Encounters Summary R[1..*] 1.3.6.1.4.1.19376.1.12.1.2.20 *It is recommended that ntent nsumers present the information from both Procedure Sections. It is also recommended that the Ocular History be presented separately from the Procedure Sections. Example XML de ClinicalDocument xmlns='urn:hl7-org:v3 > <typeid extension="pocd_hd000040" root="2.16.840.1.113883.1.3"/> <templateid root='2.16.840.1.113883.10.20.22.1.2'/> <templateid root='1.3.6.1.4.1.19376.1.12.1.1.4'/> <id root=' ' extension=' '/> <code code='68887-9' displayname='general eye evaluation' codesystem='2.16.840.1.113883.6.1' codesystemname='loinc'/> <title> Ophthalmology Summary Note</title> <effectivetime value='20151004012005'/> <confidentialityde code='n' displayname='normal' codesystem='2.16.840.1.113883.5.25' codesystemname='nfidentiality' /> <languagede code='en-us'/> : <templateid root='2.16.840.1.113883.10.20.22.2.21'/> <!-- Optional Advanced Directive Section content --> 19 Mary Jungers 12/19/2016 7:17 PM Formatted: Font:Not Bold Mary Jungers 12/19/2016 7:17 PM Formatted: Don't keep with next Don Van Syckle 5/31/2017 11:47 AM Eye Care HL7, HEALTH LEVEL SEVEN, 2... [28] 2.0 yyyy-mm-dd

630 635 640 645 650 655 660 665 670 675 680 685 <templateid root='2.16.840.1.113883.10.20.22.2.6.1'/> <!-- Required Allergies Section content --> <templateid root='2.16.840.1.113883.10.20.22.2.22'/> <!-- Optional Encounters Section content --> <templateid root='2.16.840.1.113883.10.20.22.2.22.1'/> <!-- Required Encounters Section content --> <templateid root='2.16.840.1.113883.10.20.22.2.15'/> <!-- Required if known Family History Section content --> <templateid root='2.16.840.1.113883.10.20.22.2.14'/> <!-- Required if known Functional Status Section content --> <templateid root='2.16.840.1.113883.10.20.22.2.2'/> <!-- Optional Immunizations Section content --> <templateid root='2.16.840.1.113883.10.20.22.2.23'/> <!-- Optional Medical Equipment Section content --> <templateid root='2.16.840.1.113883.10.20.22.2.1.1'/> <!-- Required Medications Section content --> <templateid root='2.16.840.1.113883.10.20.22.2.18'/> <!-- Optional Payers Section content --> 20 HL7, HEALTH LEVEL SEVEN, 2... [29] 2.0 yyyy-mm-dd

690 695 700 705 710 715 <templateid root='2.16.840.1.113883.10.20.22.2.10'/> <!-- Optional Plan of Care Section content --> <templateid root='2.16.840.1.113883.10.20.22.2.5.1'/> <! Required Problems Section content --> <templateid root='2.16.840.1.113883.10.20.22.2.7.1'/> <! Required if Known Procedure Section content --> <templateid root='2.16.840.1.113883.10.20.22.2.3.1'/> <! Required if Known Results Section content --> 720 725 730 735 740 745 750 <templateid root='2.16.840.1.113883.10.20.22.2.17'/> <!-- Required if known Social History Section content --> <templateid root='2.16.840.1.113883.10.20.22.2.4'/> <!-- Optional Vital Signs Section content --> <templateid root='2.16.840.1.113883.10.20.22.2.7'/> <!-- Required if known Procedure (entries optional) Section content --> <templateid root='1.3.6.1.4.1.19376.1.12.1.2.3'/> <!-- Required if known Ocular History Section content --> <templateid root='1.3.6.1.4.1.19376.1.12.1.2.20'/> <!-- Required Ocular Encounters Summary Section content --> 21 HL7, HEALTH LEVEL SEVEN, 2... [30] 2.0 yyyy-mm-dd

755 </structuredbody> </ClinicalDocument> 6.3.2 CDA Section ntent Modules 760 6.3.2.20 Ocular Encounter Summary 1.3.6.1.4.1.19376.1.12.1.2.20 Template ID 1.3.6.1.4.1.19376.1.12.1.2.20 Parent Template General Description C[1..1] Section de Opt Data Element or Section Name Assessment and Plan The ocular encounter section shall contain summary information from patient s eye care encounters. 78513-9, LOINC, Ophthalmology Summary of encounters note Template ID Subsections 2.16.840.1.113883.10.20.22.2.9 Specification Document HL7 C-CDA nstraint Shall include an Assessment and Plan Section or an Assessment Section and a Plan Section. Don Van Syckle 12/20/2016 5:42 PM appliedforvalue Don Van Syckle 12/20/2016 5:42 PM Ocular Encounter Summary C[1..1] C[1..1] R[0..1] R[0..1] R[0..1] R[0..1] Assessment 2.16.840.1.113883.10.20.22.2.8 HL7 C-CDA Shall include an Assessment and Plan Section or an Assessment Section and a Plan Section. Plan of Care 2.16.840.1.113883.10.20.22.2.10 HL7 C-CDA Shall include an Assessment and Plan Section or an Assessment Section and a Plan Section. Intraocular Pressure Refractive Measurements Lensometry Measurements Ophthalmic Medications 1.3.6.1.4.1.19376.1.12.1.2.2 1.3.6.1.4.1.19376.1.12.1.2.9 1.3.6.1.4.1.19376.1.12.1.2.10 1.3.6.1.4.1.19376.1.12.1.2.4 22 EYECARE TF-2: 6.3.2.11 EYECARE TF-2: 6.3.2.9 EYECARE TF-2: 6.3.2.10 EYECARE TF-2: 6.3.2.4 HL7, HEALTH LEVEL SEVEN, 2... [31] 2.0 yyyy-mm-dd

R[0..1] Visual Acuity 1.3.6.1.4.1.19376.1.12.1.2.7 R[0..1] Posterior Segment 1.3.6.1.4.1.19376.1.12.1.2.18 EYECARE TF-2: 6.3.2.8 EYECARE TF-2: 6.3.2.17 If Known, shall contain one set of Visual Acuity fields based upon the following observation/code priority list: 1 419775003, SNOMED CT, Best rrected Visual Acuity 2-111686, DCM, Habitual Visual Acuity 3-420050001, SNOMED CT, Uncorrected Visual Acuity If the observation/code is not one of the above codes, this section shall not be included. If known, shall be included if the observation/code contains one or more of the following values: 637369018, SNOMED CT, Optic cup/disc ratio observable, 370937003, SNOMED CT, Vertical cup/disc ratio observable, 370938008, SNOMED CT, Horizontal cup/disc ratio observable 765 770 775 780 785 Example XML de <templateid root='1.3.6.1.4.1.19376.1.12.1.2.20'/> <id root=' ' extension=' '/> <code code='78513-9' displayname='ophthalmology Summary of encounters note' codesystem='2.16.840.1.113883.6.1' codesystemname='loinc'/> <text> Text as described above </text> <templateid root='2.16.840.1.113883.10.20.22.2.9'/> <!-- nditional Assessment and Plan Section content --> <templateid root='2.16.840.1.113883.10.20.22.2.8'/> <!-- nditional Assessment Section content --> 23 Don Van Syckle 5/31/2017 12:27 PM appliedforvalue Don Van Syckle 5/31/2017 12:28 PM Ocular encounter summary HL7, HEALTH LEVEL SEVEN, 2... [32] 2.0 yyyy-mm-dd

795 800 805 810 815 820 825 830 835 840 <templateid root='2.16.840.1.113883.10.20.22.2.10'/> <!-- nditional Plan of Care Section content --> <templateid root='1.3.6.1.4.1.19376.1.12.1.2.2'/> <! Required if Known Intraocular Pressure Section content --> <templateid root='1.3.6.1.4.1.19376.1.12.1.2.9'/> <! Required if Known Refractive Measurements Section content --> <templateid root='1.3.6.1.4.1.19376.1.12.1.2.10'/> <! Required if Known Lensometry Measurements Section content --> <templateid root='1.3.6.1.4.1.19376.1.12.1.2.4'/> <! Required if Known Ophthalmic Medications Section content --> <templateid root='1.3.6.1.4.1.19376.1.12.1.2.7'/> <! Required if Known Visual Acuity Section content --> <templateid root='1.3.6.1.4.1.19376.1.12.1.2.18'/> <! Required if Known Posterior Segment Section content --> 24 HL7, HEALTH LEVEL SEVEN, 2... [33] 2.0 yyyy-mm-dd